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Vical Announces Breakthrough for Pandemic Influenza DNA Vaccines With Preliminary Human Data
Date:7/16/2008

SAN DIEGO, July 17 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced a breakthrough with preliminary clinical trial data demonstrating that DNA vaccines can safely achieve significant immune responses against H5N1 pandemic influenza in humans. DNA vaccines are fundamentally different from conventional vaccines because they do not contain any part of the virus itself, and may offer compelling advantages in response to a pandemic outbreak because of significantly reduced development and manufacturing times.

Specifically, preliminary human safety and immunogenicity data obtained in a 100-subject Phase 1 trial of the company's Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines demonstrated for the first time that DNA vaccines have achieved potentially protective levels of antibody responses (defined as hemagglutination inhibition, or HI, titers of at least 40; responses ranged from 40 to 640) in up to 67% of evaluable subjects in the higher dose cohorts. No significant safety issues were observed at any of the Vical vaccine doses tested. These results support further development of Vaxfectin(R)-formulated DNA vaccines, and could position them as potential alternatives to conventional vaccines.

"The preliminary results from this Phase 1 trial indicate for the first time that an adjuvanted DNA vaccination against H5N1 influenza is well-tolerated and can induce impressive antibody responses even against this relatively weak immunogen," said Robert B. Belshe, M.D., Dianna and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology, Saint Louis University School of Medicine, who was the lead external safety monitor for the study. "Successful development of a safe and effective DNA
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